Influence of Caloric Restriction and Resveratrol in the Sirtuin System in Women and Men Aged 55 to 65 Years
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ClinicalTrials.gov Identifier: NCT01668836 |
Recruitment Status
:
Completed
First Posted
: August 20, 2012
Results First Posted
: April 18, 2016
Last Update Posted
: April 18, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Vascular System Injuries Lipid Metabolism Disorders Endothelial Disfunction | Drug: Resveratrol Behavioral: Caloric restriction | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 48 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Influence of Caloric Restriction and Resveratrol in the Sirtuin System in Women and Men Aged 55 to 65 Years. |
Study Start Date : | August 2012 |
Actual Primary Completion Date : | July 2014 |
Actual Study Completion Date : | December 2014 |

Arm | Intervention/treatment |
---|---|
Experimental: men with resveratrol
12 men will receive a pill with 500mg of resveratrol daily for 30 days
|
Drug: Resveratrol
1 pill daily containing 500 mg/d of resveratrol for 30 days
|
Experimental: women with resveratrol
12 women will receive a pill with 500mg of resveratrol daily for 30 days
|
Drug: Resveratrol
1 pill daily containing 500 mg/d of resveratrol for 30 days
|
Active Comparator: men with caloric restriction
12 men will follow a 1000 calories per day diet for 30 days
|
Behavioral: Caloric restriction
Diet of 1000kcal per day for 30 days
|
Active Comparator: women with caloric restriction
12 women will follow a 1000 calories per day diet for 30 days
|
Behavioral: Caloric restriction
Diet of 1000kcal per day for 30 days
|
- Direct Evaluation of the Sirtuin 1 Gene Expression [ Time Frame: 30 days post-treatment ]The Sirtuin 1 gene expression was measured by real time PCR in peripheric blood. Unit of measure was arbitrary unit. "Arbitrary unit was relative to the control gene expression (control gene = 1)".
- Sirtuin [ Time Frame: 30 days post-treatment ]Sirtuin plasma levels before and 30 days post-treatment
- Influence of the Sirtuin 1 System on Lipid Profile, Glucose, and C-reactive Protein. [ Time Frame: 30 days post-treatment ]
For indirect analysis of the sirtuin 1 system, the following procedures will be done before and after the intervention with caloric restriction or resveratrol administration:
- serum HDL, LDL, lipoprotein(a), C reactive protein, glucose.
- Influence of the Sirtuin 1 System on Apolipoproteins AI and B. [ Time Frame: 30 days post-treatment ]
For indirect analysis of the sirtuin 1 system, the following procedures will be done before and after the intervention with caloric restriction or resveratrol administration:
- apolipoproteins AI and B
- Influence of the Sirtuin 1 System on Estradiol [ Time Frame: 30 days post-treatment ]
For indirect analysis of the sirtuin 1 system, the following procedures will be done before and after the intervention with caloric restriction or resveratrol administration:
- estradiol
- Influence of the Sirtuin 1 System on Platelet Aggregation. [ Time Frame: 30 days post-treatment ]
For indirect analysis of the sirtuin 1 system, the following procedures will be done before and after the intervention with caloric restriction or resveratrol administration:
- platelet aggregation by ADP and norepinephrine.
- Influence of the Sirtuin 1 System on Biomarkers [ Time Frame: 30 days post-treatment ]
For indirect analysis of the sirtuin 1 system, the following procedures will be done before and after the intervention with caloric restriction or resveratrol administration:
- non-esterified fatty acids, insulin, luteinizing hormone, follicle stimulating hormone.
- Influence of the Sirtuin 1 System on Estrone and Norepinephrine. [ Time Frame: 30 days post-treatment ]
For indirect analysis of the sirtuin 1 system, the following procedures will be done before and after the intervention with caloric restriction or resveratrol administration:
- estrone, norepinephrine.
- Influence of the Sirtuin 1 System on Receptor for Advanced Glycation End Products (RAGE) Gene Expression [ Time Frame: 30 days post-treatment ]
For indirect analysis of the sirtuin 1 system, the following procedures will be done before and after the intervention with caloric restriction or resveratrol administration:
- RAGE gene expression
- "Arbitrary unit was relative to the control gene expression (control gene = 1)"
- Influence of the Sirtuin 1 System on Thromboelastography Clot Formation. [ Time Frame: 30 days post-treatment ]
For indirect analysis of the sirtuin 1 system, the following procedures will be done before and after the intervention with caloric restriction or resveratrol administration:
-dynamics of clot formation: clot onset time and clot complet
- Influence of the Sirtuin 1 System on Thromboelastography. [ Time Frame: 30 days post-treatment ]
For indirect analysis of the sirtuin 1 system, the following procedures will be done before and after the intervention with caloric restriction or resveratrol administration:
- slope of clot formation dynamics
- Influence of the Sirtuin 1 System on Max Elasticity of Clot on Thromboelastography. [ Time Frame: 30 days post-treatment ]
For indirect analysis of the sirtuin 1 system, the following procedures will be done before and after the intervention with caloric restriction or resveratrol administration:
-max elasticity of clot on thromboelastography
- Differences Between Men and Women. [ Time Frame: 30 days ]We will also compare women vs men baseline and final data.

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Ages Eligible for Study: | 55 Years to 65 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- clinical history, physical examination and electrocardiogram normal
Exclusion Criteria:
- premenopausal women (less than 1 year of natural amenorrhea)
- Body mass index ≥ 35 kg/m2
- Smoking
- Severe hypertension (diastolic blood pressure ≥ 110 mmHg)
- Severe dyslipidemia (triglycerides ≥ 500mg/dL, total cholesterol ≥ 300mg/dL)
- Diabetes
- Previous using previous statins or hormone replacement therapy. Other exclusion criteria are: chronic renal failure (serum creatinine ≥ 2.0 mg / dl), hepatic, endocrine, hematologic, respiratory or metabolic clinically significant.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01668836
Brazil | |
INCOR - Heart Institute | |
São Paulo, Brazil, 05403-900 |
Principal Investigator: | Antônio de Pádua Mansur, PHD | InCor Heart Institute |
Responsible Party: | ANTONIO DE PADUA MANSUR, PHD, InCor Heart Institute |
ClinicalTrials.gov Identifier: | NCT01668836 History of Changes |
Other Study ID Numbers: |
788012 2012/01051-5 ( Other Grant/Funding Number: FAPESP - SAO PAULO RESEARCH FOUNDATION ) |
First Posted: | August 20, 2012 Key Record Dates |
Results First Posted: | April 18, 2016 |
Last Update Posted: | April 18, 2016 |
Last Verified: | March 2016 |
Keywords provided by ANTONIO DE PADUA MANSUR, InCor Heart Institute:
sirtuin atherosclerosis longevity |
calorie restriction resveratrol vascular reactivity |
Additional relevant MeSH terms:
Resveratrol Metabolic Diseases Lipid Metabolism Disorders Vascular System Injuries Vascular Diseases Cardiovascular Diseases Wounds and Injuries Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents |
Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Antineoplastic Agents, Phytogenic Antineoplastic Agents Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Enzyme Inhibitors Platelet Aggregation Inhibitors Antimutagenic Agents Anticarcinogenic Agents |